DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Part of plantprohibitedGenusSpeciesCommon/Local Name(whole plantunlessotherwisespecified)Constituent(s) ofconcernRelatedsubstance:Urginea indica,Urgineapancreatium,Urginea scillaEphedra All species Ma HuangEphedrine,PseudoephedrineGelsemiumsempervirensYellowJessamine,EveningTrumpet,Carolina JessamineGelsemineHyoscyamusmuticusEgyptianhenbaneHyoscyamineHyoscyamus niger Black henbaneHyoscyamineatropineLobeliainflataLobelia,pokeweed,Indian tobacco,gagroot,asthma weed,vomitwort,bladderpod,rapuntiuminflatum.LobelineLobelia nicotianifolia Wild Tobacco LobelineMitragyna speciosa Daun Ketum MitrogynineNicotianatabacumCommontobaccoNicotineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 248
Drug Registration Guidance Document (<strong>DRGD</strong>)Part of plantprohibitedGenusSpeciesCommon/Local Name(whole plantunlessotherwisespecified)Constituent(s) ofconcernPapaver somniferum Opium poppyMorphine,codeine,hydrocodone,meperidine,methadone,papaverineYohimbe,JohimbePausinystaliayohimbeSyn.Corynanthejohimbi,Corynanthe yohimbiYohimbinePhysostigma venenosum Calabar bean PhysostigminePilocarpusmicrophyllusPilocarpusjaborandi,jaborandiPilocarpinePunica granatum Pomegranate Bark Iso-PellatrierineRauwolfiaserpentinaIndiansnakeroot,SerpentinerootReserpineRauwolfiavomitoriaAfricanserpentwoodReserpineSchoenocaulonofficinaleVeratrumofficinaleSabadilla,VeratrineScillaebulbusSea onion,SquillSolanumnigrumBlacknightshadeSolanineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 249
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Page 198 and 199: Drug Registration Guidance Document
Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233: - All information must be provided
Page 242 and 243: 1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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